Quality Assurance Medical Device

Objective

To obtain a chemistry laboratory position that will allow me to develop and

use new and existing analytical test methods to determine quantity, quality

and purity of new compounds

Specialties:

Six years experience in Pharmaceutical industry and Six years in Analytical

laboratory in consumer products testing

Education

Bachelor Of Science Degree In Chemistry 1998

Shanghai Fudan University

Professional Experience

Cambrex Corporation ( June 2012 - Jan 2014 ) IOWA

Pharmaceutical Chemist

Cambrex corporation is an innovative life sciences company dedicated to

providing quality small molecule products to accelerate the development and

commercialization of therapeutics for the Pharma and Biotech industries

Responsibilities:

. Performing analytical chemistry assays based on new and existing

methodologies for more than 20 different compounds,

. Operating analytical instrumentation such as HPLC, GC, GC/MS, LC/MS,

FTIR, Titrator, Particle Size Analyzer, Karl Fischer,dissolution,

NMR, Aanalyst (Atomic Absorption Spectrometer),DSC(SDT Q600), TOC,TLC

.

. Calibrated, tuned,performed maintenance, standardized,troublshooted

and repaired several Agilent GCS andGC/MSs

. Performs wet Chemistry tests (i.e., pH, titration, heavy metals,extration etc.).

. Maintains appropriate documentation (records and lab notebooks)

according to cGMPS and internal SOPs.

. Participated Validating analytical testing methodology used to control

raw materials, production intermediates, and final products

. Participated in QA/QC by reading and revising SOPs and updating reporting

difficulties and possible solutions to my supervisor

. Managed the general laboratory inventory and order necessary supplies

. Experience generating and following test protocols & documenting results

using good lab notebook procedures

. Experience with Water's Empower and Agilent's ChemStation software

Diamond Diagnostics Inc. (October 2011- Jan 2012 3 Month contract )

( a vertically integrated manufacturer and refurbishing company

specializing in Blood Gas,Electrolyte,Chemistry, Immunology,Hematology

and coagulation instrumentation and support products)

R&D lab Technician in Rresearch and Development department

. Perform Hematology Reagent Product Manufacturing and related ongoing

activities

. Evaluate electrodes controls and reagents for use on blood gas, chemistry,hematology

. Perform Product Quality Control and related ongoing activities

. Make and evaluate formulation

. Test for buffer capacity

. Measurement for Na, K,Cl, Ca,Li concentration

Bureau Veritas, Consumer Products Services Inc. Taunton MASSACHUSETTS (Sep

2004 - Sep 2011)

Facility Closure

BVCPS is a worldwide quality assurance provider serving the global consumer

product and retail markets. BVCPS provides an extensive range of

specialized services including consulting, testing, inspections, training

and outsourcing for a full-range of consumer products including electrical

and electronic products, hardiness, textiles, toys and juvenile products,

premiums, health beauty, household and food products, revenue $2.1 Billion

Analytical Lab Technician (2004 - Sep 2011)

Responsibilities:

. Prepared digest extract and instrumental analyze Consumer products to

determinate lead cadmium and heavy metal by using instrument such as ICP-

OES, under CPSIA ; Restricted substance testing for raw material and

products

. Performed instrumental analysis UV-Vis Spectrophotometer for

determination of free and bonded formaldehyde content

. Performed identify PVC or other polymers by FTIR (Fourier Transform

Infrared Spectroscopy) to analyzed compounds for their chemical structure

or to confirm a compounds identity

. Performed formulation of reagents,controls, buffer and calibration with

good manufacturing practices

Shanghai Donghai Pharmaceutical Inc. shanghai China(1998-2004)emigrated to

The States

(Established in December 1948, Shanghai Donghai is a leading

pharmaceutical, biopharmaceutical, and medical device outsourcing company

with operations in China, The complete specification of the quality

management system certified by the State Food and Drug Administration in

full compliance with cGMP standards)

Analytical Chemist

Responsibilities:

. Performed determination of water and fat soluble Vitamins and the level

of cholecalciferol (Vitamin D3) of cod liver oil by High Performance

liquid chromatography,(Agilent ChemStation), and UV Vis

Spectrophotometer

. Performed determination of fatty acid methyl ester (FAME) in the cod

liver oil by GC/ Gas chromatography-mass spectrometry

. Carried out drug releasing tests from hydrogel and monitor by UV/Visible

Spectrophotometer

. Performed Analyzed drug substance and drug product on prescription

medications for content uniformity, dissolution, assay,

degradation/impurities, water content of GMP analytical instrumentation

. Maintained laboratory equipment under GLP and GMP conditions and

recording data in notebook and computer database, per established SOP

procedures

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